510(k) K860147
K860147 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "CARBON DIOXIDE ABSORBENTS". The FDA issued a decision of Substantially Equivalent on February 28, 1986. The device falls under product code CBL (Absorbent, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5300. Dentsply Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1986
- Date Received
- January 15, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbent, Carbon-Dioxide
- Device Class
- Class I
- Regulation Number
- 868.5300
- Review Panel
- AN
- Submission Type